Proposal Developer/Clinical Project ManagerOutcome Software, Inc.

THIS JOB HAS EXPIRED

Description

When you work for Quintiles you work for the world's leading Pharmaceutical Services Company. We offer product development and commercialization services to the Pharmaceutical, Biotechnology and Medical Devices industries. Our leading-edge capabilities provide healthcare companies with the potential to bring new medicines/devices through development and registration to the market place more quickly, with supporting medical and drug data that will significantly advance the cost effectiveness and quality of healthcare provision. Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialize every single one.

PURPOSE
We are currently recruiting for a Proposal Developer/Clinical Project Manager to provide subject matter expertise, operational guidance, and writing support for proposal development and to manage the execution of the assigned regionally-based Real World Late Phase Observational & Interventional study(ies) per Contract, from initiation through to closeout. Ensure that all study management and project deliverables are completed to the Sponsor?s satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices..
Qualifications

RESPONSIBILITIES
Manage and co-ordinate efforts of cross-functional project teams to support effective study achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
Review Requests For Proposal (RFP). Identify information for proposal text and budget development and work closely with proposal development team to prepare and finalize proposals
Prepare text and budget for proposals, rebids and related documents
Provide support and assistance to other Proposal Developers in the delivery of assigned opportunities
May act as Team Lead on assigned projects, to develop proposals and budgets
Participate in strategy calls to discuss customer requirements and identify discrepancies in customer information
Perform quality control edits on all documents and participate in the finalization of documents and distribution to the customer and internal departments
Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.
Collect information on team performance against contract, customer expectations, and project baselines.
Lead problem solving and resolution efforts to include management of risk, contingencies and issues.
Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
Provide input for the development of proposals for new work and manage project budgets.
Provide input to line managers of their project team members? performance relative to project tasks.
Prepare and present project information at internal and external meetings.
Participate in proposal development and in the bid-defense process with guidance and supervision.
Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of, and skill in applying, applicable Real World Late Phase clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. EMEA Pharmacovigilance legislation, GRACE Principles
Good therapeutic and protocol knowledge
Experience in observational research and knowledge of CRO industry
Strong experience in proposal writing with a track record of leading opportunities to award
Strong communication and interpersonal skills, including good command of English language

Ability to interpret RFPs and protocols
Possess strong analytical skills and excellent verbal and written communication skills
Ability to establish and maintain effective working relationships with coworkers, managers and customers
Good problem solving skills
Demonstrated ability to deliver results to the appropriate quality and timeline metrics
Good teamwork skills
Excellent customer service skills
Good presentation skills
Good judgment
Strong software and computer skills, including MS Office applications and costing models
Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field and 5 years? clinical research experience, including 2 years? direct experience in proposals, project management, and clinical operations; or equivalent combination of education, training, and experience.
Primary Location: United States
Organization: USA02 - US Clinical Development Svcs